Is Colostomy Closure Without Mechanical Bowel Preparation Safe in Pediatric Patients? Randomized Clinical Trial.

Not Applicable

• Conditions: Colostomy; Surgical Anastomosis
• Interventions: Drug: No Mechanical Bowel Preparation; Drug: Mechanical Bowel Preparation

• Registration Number: NCT02530346
• Lead Sponsor: Hospital Infantil de Mexico Federico Gomez

Brief Summary

This study will help determine wether mechanical bowel preparation before a colostomy closure is necessary in pediatric population, in order to avoid surgery related complications (surgical site infection and anastomosis leakage).

Half of the population will go through the mechanical bowel prep before colostomy closure and the other half won´t. Complications rate will be compared among both groups.

Detailed Description

Mechanical bowel preparation is based on administering osmotic laxatives and enemas through the stomas, in order to diminish solid stool and bacterial load on the colon prior to a colostomy takedown. This was thought to decrease the surgery related complications.

However mechanical bowel preparation can cause discomfort in patients as well as other complications like hydro electrolyte imbalance.

Studies in adult population have shown that there is not a significant difference in the presence of surgery related complications in patients that received bowel prep and those who did not.

There is not enough evidence in pediatric patients that this affirmation is also true.

Study Timeline

• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Study Start: 2015-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-06
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Pediatric patients who are to be submitted to a colostomy closure

Exclusion Criteria

• patients with more than 3 abdominal surgeries
• patients with primary or acquired immunodeficiencies (including malnourishment)
• Patients in which the distal intestine is closed in a Hartmann´s pouch

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Mechanical Bowel Preparation	No Mechanical Bowel Preparation	Patients will not receive any preparation prior to surgery
Mechanical Bowel Preparation	Mechanical Bowel Preparation	Patients will receive enteric polyethylene glycol at 100 ml/kg/dose during 4 hours, and up to 3 times, prior to surgery. Enemas with normal saline 20 ml/kg/do will be administered through the stomas 3 times a day

Primary Outcome Measures

Name	Time	Method
Surgery Related Complications	up to 30 days	Presence of surgical site infections according to the Centers for Disease Control classification, Presence of anastomotic leakage

Trial Locations

Locations (1)

Hospital Infantil de Mexico Federico Gomez; 🇲🇽 Mexico City, Mexico